Ramus Medical Technologies is developing instrumentation that will allow a member of the surgical team to construct a non-kinking and compliant conduit from suitable autologous tissue sources in a rapid and repeatable manner: Rapidgraft Arterial Vessel SubstituteTM. A pericardial conduit will be evaluated in a canine model with respect to intra-operative graft construction, implantation, duration of patency, safety and biological performance/host tissue healing response as an aorto-coronary bypass graft. Benchmarks for evaluation will be comparison to an autologous saphenous vein or free internal mammary artery graft. Recent evidence from animal studies has demonstrated that autologous pericardial conduits constructed with the Rapidgraft methodology undergo unique healing characterized by replacement of tissue, remodeling and endothelialization in the reformation of an artery-like conduit. Should this distinctive biological behavior translate to long-term patency, these products may be used in instances where a patient lacks useable arterial or venous conduit and where use of a homograft or synthetic vessel is not desirable. In addition, this technology will complement strategies designed to minimize the size and extent of surgical incisions for open heart surgery, including port-access or robotic-assisted procedures and deep incisions in the leg to harvest saphenous veins. PROPOSED COMMERCIAL APPLICATIONS: The need for a successful, alternative coronary artery bypass conduit is immense as up to 20% of patients requiring such procedures lack suitable saphenous vein. The proposed technique is expected to provide a readily available, improved outcome and lower cost alternative to currently available options. A successful product would virtually stand alone in the market for small diameter (< 6mm) prosthetic vascular grafts for CABG procedures which is estimated to exceed $1 .0 billion worldwide.
